Actively Recruiting
EVM16 Injection As a Single and Combination with Tislelizumab in Solid Tumors
Led by Peking University · Updated on 2025-03-18
78
Participants Needed
2
Research Sites
173 weeks
Total Duration
On this page
Sponsors
P
Peking University
Lead Sponsor
S
Shanghai Cancer Centre
Collaborating Sponsor
AI-Summary
What this Trial Is About
The goal of this clinical trial is to learn the side effects, safety and effect of a tumor vaccine (EVM16) alone or in combined with an anti-PD-1 antibody (tislelizumab) . This clinical trial will include solid tumor patients who failed standard treatment. The main questions to answer are: Safety of EVM16. Suitable dose of EVM16. Effects of EVM16 combined with tislelizumab.
CONDITIONS
Official Title
EVM16 Injection As a Single and Combination with Tislelizumab in Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Recurrent or metastatic solid tumors confirmed by pathology and not suitable for surgery or local therapy
- Advanced or recurrent solid tumors with failure of prior standard treatments
- Expected survival longer than 6 weeks at time of consent
- Adequate organ function
- ECOG Physical Status Score of 0 or 1
- Willingness to provide archival or fresh tumor tissue samples for EVM16 production
- Completed adequate washout period from previous treatments before first study dose
- At least one measurable tumor lesion according to RECIST version 1.1 criteria before enrollment
You will not qualify if you...
- Symptomatic, untreated, or curable primary central nervous system malignancies or CNS metastases
- Uncontrolled co-morbidities
- Stroke or transient ischemic attack within 4 months prior to consent
- Prolonged QTcF interval during screening (male >450 ms; female >470 ms)
- Left ventricular ejection fraction below 50% during screening
- Diagnosis or history of immunodeficiency, active or past autoimmune diseases requiring systemic steroids or immunosuppressive therapy
- Positive HIV test or AIDS history
- Co-infection with HBV and HCV
- Active infection needing systemic therapy
- Current use of other investigational medications
- Previous treatment with cell therapy, tumor vaccines, cytokines, or growth factors for cancer control
- Prior intolerance to tislelizumab leading to its permanent discontinuation
- History or presence of significant lung disease
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Beijing Cancer Hospital
Beijing, Beijing Municipality, China, 100142
Actively Recruiting
2
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 200135
Actively Recruiting
Research Team
L
Lin Shen, MD
CONTACT
Y
Yanshuo Cao, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here